Biofire Diagnostics, LLC - FDA 510(k) Cleared Devices
28
Total
24
Cleared
4
Denied
Biofire Diagnostics, LLC has 24 FDA 510(k) cleared microbiology devices. Based in Salt Lake City, US.
Latest FDA clearance: Aug 2025. Active since 2015.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Biofire Diagnostics, LLC
28 devices
Cleared
Aug 14, 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
Microbiology
272d
Cleared
Jan 16, 2025
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
Microbiology
29d
Cleared
Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...
Microbiology
14d
Cleared
Nov 07, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Microbiology
90d
Cleared
May 30, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
Microbiology
30d
Cleared
Mar 26, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
Microbiology
187d
Cleared
Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
Microbiology
29d
Cleared
Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Microbiology
29d
Cleared
Oct 27, 2022
FilmArray Pneumonia Panel plus
Microbiology
59d
Not Cleared
Apr 29, 2022
BioFire Joint Infection (JI) Panel
Microbiology
549d
Cleared
Sep 22, 2021
FilmArray Pneumonia Panel
Microbiology
26d
Not Cleared
Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
Microbiology
302d